NCT04951869

: Protescal: Prevention of Hypertrophic Scar and Keloid Formation Post Caesarean Section

Assessing the Effectiveness of Protescal In Preventing Post Caesarean Section Hypertrophic Scar and Keloid

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Universiti Kebangsaan Malaysia Medical Centre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aimed to evaluate the effectiveness of Protescal in preventing post caesarean section hypertrophic scar and keloid formation.

Detailed description

A randomized controlled trial was conducted for six months involving 90 women who underwent caesarean section without any history of previous abdominal surgery and who were planning for further pregnancy. They were randomized into two groups. The Protescal group was given Protescal gel which was applied over the uterine incision site and subcutaneous tissue layer prior to skin closure (n = 45), whereas in the control group, no Protescal gel was applied (n = 45). The primary outcome was to assess the healing of the external scar.

Conditions

• Caesarean Wound
• Hypertrophic Surgical Scar
• Keloid Scar Following Surgery

Interventions

Type	Name	Description
DRUG	Protescal gel	Protescal gel (0.5 mL) was again applied over the subcutaneous tissue prior to skin closure in Protescal group

Timeline

• Start date: 2017-04-26
• Primary completion: 2017-10-31
• Completion: 2017-11-16
• First posted: 2021-07-07
• Last updated: 2021-07-07

Locations

1 site across 1 country: Malaysia